Medical Innovation Acceleration Act of 2025

HR 88, the Medical Innovation Acceleration Act of 2025, exempts non-invasive diagnostic devices from standard medical device regulations under federal law. It specifically defines "non-invasive" as devices that don’t penetrate skin, insert into the body, or cause significant tissue changes (like ionizing radiation), directly affecting manufacturers of such devices. This change streamlines regulatory pathways for these tools by removing them from the device classification system. The bill focuses solely on clarifying regulatory scope, with no new funding or requirements.